FDA News: FDA Updates Various eCTD Documents

March 24, 2021

Recently, the FDA updated a number of documents related to eCTD.  These changes are summarized in the eCTD Submission Standards document, which provides a consolidated change history and links to supporting documents.

Support for Modeling and Simulation.  

This is an interesting area which is evolving rapidly.  FDA has signaled support for supporting M&S to accelerate approvals of drug and biological products. In 2018, the FDA started a Model-Informed Drug Development (MIDD) Pilot Program.  This provided sponsors with the opportunity to discuss MIDD approaches for development programs.  According to an article published by DIA

“Points in the drug development and review process where the agency sees the potential of M&S include exploratory development and dose finding; evaluation of a sponsor’s proposed late-phase protocol, study design, and analysis plan during the IND phase; evaluation of a completed trial submitted during the NDA phase; and postapproval “what if” benefit/risk scenario assessments.”

To support this, the FDA now accepts a variety of Modeling & Simulation file types: .cmpx, cmpz, .wksx, .wksz, ,lbrx, .lbrz, .mdb, .pbk, .opd, .psd, .spd .c, .cpp, .m, .mat, .rmd, .phxproj, .py, .jl, .cas, .dat.  Details appear in Specifications for File Format Types Using eCTD Specification.

Updates to eCTD Validation Criteria

 The Validation Criteria includes new and updated validation checks:

“Update to the effective date of the eCTD Validation Criteria 1734, 1735, 1736 (see Technical Rejection Criteria for Study Data), 1737, and 1789, and new eCTD Validations (1551, 1553, 1554) which support the Promotional Labeling and Advertising Materials Guidance”

Of these, the most interesting are new items related to promotional material submissions.

  • 1551: 2253 submission does not include Product Labeling 
  • 356h Form not allowed in Promotional Labeling Submissions [These should include 2253 instead]

These are High severity     (serious technical error which prevents the processing of the submission and will require resubmission. The submission is considered not received by FDA).  They indicate that sponsors are still making basic, fundamental mistakes in AdPromo submissions.  

Update to List of FDA forms

The  form-types.xml file was updated to add Form FDA 3938 for the Drug Master File.

Announcement of Effective Date for Technical Rejection Criteria for Study Data

Technical Rejection Criteria for Study Data Study data standards are required in clinical and nonclinical studies that start after December 17, 2016. 1 Technical rejection criteria have been added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines below2 and will become effective on September 15, 2021.

Release of CDER Data Standards Program 2020 Annual Assessment.  

This document reports progress against six goals:

  • Goal 1: Incorporate data standards to support more efficient, science based pre-market review of medical products.
  • Goal 2: Improve the post-market risk management strategies and pharmacovigilance and surveillance of medical products by using data standard
  • Goal 3: Implement common data standards to improve the quality and integrity of marketed medical products.
  • Goal 4: Promote innovation in the development and use of data standards.
  • Goal 5: Ensure effective communication and collaboration with stakeholders on data standards
  • Goal 6: Improve the management and usability of the volume of information through data standards

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